RecruitingPhase 1NCT05610865

Efficacy of Adipose Tissue Derived Stem Cells for the Treatment of Diabetic Foot Ulcers

Autologous Adipose Tissue Derived Stromal Vascular Fraction Versus Cultured Adipose Derived Stem Cells for the Treatment of Chronic Diabetic Wounds

Sponsor

University of the Punjab

Enrollment

28 participants

Start Date

Nov 20, 2020

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Diabetic Foot Ulcer Diabetic Foot Foot Ulcer Due to Type 2 Diabetes Mellitus Foot Ulcer Diabetes Complications Foot Ulcer Due to Type 1 Diabetes Mellitus Diabetic Foot Infection Diabetic Foot Ulcer Neuropathic Chronic Diabetic Ulcer of Left Foot Chronic Diabetic Foot Ulcer of Right Foot

Summary

The aim of this study is to evaluate the therapeutic efficacy of uncultured adipose derived stromal vascular fraction (SVF) and cultured adipose derived stem cells (ASCs) both supplemented with platelet rich plasma (PRP) to treat chronic diabetic foot ulcers. It will increase the pragmatic potential of both types of cells as PRP is rich in survival and chemotactic factors. Moreover, the autologous nature of the proposed study will ensure safety of its use in diabetic patients and will unveil the more effective therapeutic option for treatment of foot ulcer wounds.

Eligibility

Min Age: 20 YearsMax Age: 60 Years

Inclusion Criteria12

Type 1 or Type 2 Diabetes Mellitus
Age 20-60 years (Male/Female)
Body mass index 20-30 kg/m2
Suitable for liposuction
Condition or Disease: Diabetic Neuropathy
Wound Type: Chronic foot ulcer
Approx. wound area: 2 cm2 - 8 cm2
Wound Condition should be of Wagner's grade I (Limited to soft tissue)
Duration of wound persistence: 6-24 Weeks
Transcutaneous oxygen pressure \> 30 mmHg, and an ankle brachial pressure index \> 0.5.
Already following an adequate off-loading method
Provided signed informed consent

Exclusion Criteria6

Uncontrolled hyperglycemia (HbAlc \> 9%)
Presence of severe clinical sign of infection
Inability to tolerate off-loading, and poor prognosis diseases including malignant tumors.
Serious chronic disease i.e hepatic, heart, renal, pulmonary diseases
Patients with critical limb ischemia and osteomylitis
Withdrawal of informed consent

Interventions

OTHERControl; Standard-of-care management

Patients will undergo conventional wound care management.

BIOLOGICALOnly PRP injection

Only PRP injected / cm2 intradermally at the border zone \& inside of wound surface bed.

BIOLOGICALPRP + SVF injection

Uncultured cells (SVF) along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.

BIOLOGICALPRP + ASCs injection

Cultured ASCs along PRP were mixed, transferred to 1 cc syringes and injected / cm2 intradermally at the border zone \& inside of wound surface bed.